OVERVIEW OF MQSA INSPECTION FINDINGS

8/22/01

Walid G. Mourad, Ph.D., CSO

Inspection Support Branch

DMQRP/OHIP/CDRH/FDA

OVERVIEW OF MQSA INSPECTION FINDINGS

BACKGROUND FINDING LEVEL DISTRIBUTION - Historical

Perspective

INSPECTION FINDINGS - Final Regulations

L1 & L2 FINDINGS - The last two years

PROGRAMS UNDERWAY

BACKGROUND

– MQSA (10/92)• Interim Regulations (10/94)• Final Regulations (published 10/97, effective 4/99)

– MQSRA (10/98)• Lay summary to all women• Release of original mammogram• Demonstration Program – Inspection Frequency

Inspection Scope

• Equipment performance including dose, phantom image, processing, & darkroom fog

• Quality assurance & quality control test records (including survey report & mammography equipment evaluations)

• Consumer complaint mechanism

• Personnel qualifications

• Medical reports and lay summaries

• Medical outcomes audit

MQSA Finding Levels

• Level 1– Serious - Warning Letter within 15 days &

subsequent facility response within 15 days

• Level 2– Moderate - 30 day response

• Level 3– Minor - Follow up at next inspection

Inspection Findings by Level - FY 95 to FY 01 (% of facilities with highest level findings)

L 1 L 2 L 3 No Finding

FY95 2.6 19.8 47.4 30.0

FY96 1.5 12.4 42.2 43.7

FY97 0.9 12.4 30.7 55.8

FY98 1.1 18.7 21.6 58.4

FY99 1.6 23.5 16.2 58.5

FY00 3.9 32.6 10.3 53.0

FY01* 3.5 28.0 10.1 58.2(to 7/31/01)

Inspection Findings by Level - FY 95 to FY 01

(% of facilities with highest level findings)

0.0

10.0

20.0

30.0

40.0

50.0

60.0

95 96 97 98 99 00 01*

Level 1

Level 2

Level 3

No Findings

* FY to 7/31/01

% of Facilities w/L1 Findings - FY95-FY01

012345

95 96 97 98 99 00 01* * (to 7/31)

% of Facilities w/L2 Findings - FY95-FY01

05

101520253035

95 96 97 98 99 00 01* * (to 7/31)

% of Facilities w/Highest Finding Levels FY 99

L 1 L 2 L 3 No Finding

FY99 (total) 1.6 23.5 16.2 58.5

FY99 (I) 0.9 18.9 18.3 61.7

(Q1-Q3)

FY99 (F) 3.6 36.8 10.1 49.2

(Q4)

% of Facilities w/L1 Findings - FY 99

012345

Q1-99 (I) Q2-99 (I) Q3-99 (I) Q4-99 (f)--- FY 99 total (1.6%)

Inspection Findings Under the Final Regulations

• Level Changes & Consequences

• L 1 & L 2 Findings ~ Two Year Results

• Future Trend

Final Regulations - Perspective

For the final regulations, FDA:– Added new requirements new findings

at all levels

– Elevated several L3 & L2 findings

– Deleted several L3 findings

As a result…– L3 findings decreased

– L2 & L1 findings increased

Number of Potential Findings

0

10

20

30

40

50

60

Interim Final

Level 1Level 2Level 3

% of Facilities w/L1 Findings FY 00

0

1

2

3

4

5

Q1-00 Q2-00 Q3-00 Q4-00

--- FY 00 total (3.9%)

% of Facilities w/L2 Findings FY 00

0

5

10

15

20

25

30

35

Q1-00 Q2-00 Q3-00 Q4-00

--- FY 00 total (32.6%)

% of Facilities w/L1 Finding FY 01

--- FYTD 01 total (3.5%)

012345

Q1-01 Q2-01 Q3-01 Q4-01** (to 7/31)

% of Facilities w/L2 Findings FY 01

05

101520253035

Q1-01 Q2-01 Q3-01 Q4-01*

--- FY 00 total (28%)

* (to 7/31)

Facilities with Level 1 Findings Recent Results (10/1/00 - 7/2/01)

Number %

L1 Findings (facilities cited) 245 3.5

Processor or Phantom QC 159 2.3

Results Communication 57 0.8

Initial Qualifications - Any Personnel 34 0.5

Other < 9 < 0.1No Valid Certificate

Unaccredited Unit in Use for => 1y

Phantom score

Underprocessing (STEP test)

No Survey for 2 years

Facilities with Level 2 Findings (as highest) Recent Results (10/1/00 - 7/2/01)

Number %L2 Findings (facilities cited) 1899 27.6

Processor or Phantom QC 862 12.6

L2 Requirements - Any Personnel 602 8.8

Med. Reports w/o Results/ID 467 6.8

Med. Outcomes Audit System 227 3.3

Survey Rep. & MEE 299 4.4

No S.O.P. Consumer Complaints 199 2.9

No S.O.P. Infection Control 110 1.6

Other < 45 < 0.7Unaccredited Unit in Use for < 1y

Phantom score

Underprocessing (STEP test)

FUTURE TREND

Based on experience to date, we believe that in the foreseeable future (~ 1 year) …

• % Facilities with L1citations < 2.5• % Facilities with L2 citations < 25.0• % Facilities with L3 citations < 10.0

PROGRAMS UNDERWAY

• Demonstration Program – Scheduled to start May 2002

– About 300 eligible facilities (14 states) in the pool

– ~ 150 will be inspected once in 2 years

• New Mammographic Modality – FFDM– Currently only GE’s Senographe 2000D (since 6/00) -

others expected in the near future

– Small number of facilities & units

– 8 hours training in FFDM are the only citations implemented to date

...for more Information on MQSA

• MQSA Internet home page:

http://www.fda.gov/cdrh/mammography

• MQSA facility hotline: 1-800-838-7715

• (DSMA) Facts on Demand: 1-800-899-0381